1. Field of the Invention
Applicant""s invention relates to a continent bladder access device. More particularly, the present invention provides for an extravesical bladder access device that can be mechanically opened to allow for urine evacuation and that self closes. There is also incorporated into the device an inflation-deflation mechanism that allows the tissue to heal and establish its blood supply prior to activation. This is accomplished through a leakproof distal port.
2. Background Information
Urinary incontinence is a major health issue that affects an estimated 10 million patients to some degree. Fifteen to thirty percent of women over age 65 in retirement communities suffer from urinary incontinence. These problems can be treated with both medications and surgery.
However, a more difficult problem in the general population, and in particular the geriatric population, is urinary retention. Since these patients will at times have overflow incontinence, they are often thought of as incontinent patients, whereas in reality they are unable to empty their bladders. In the nursing home population, patients are often chronically catheterized, since intermittent catheterization by hospital personnel is time consuming. Often these patients are unable to fully cooperate to allow such intermittent catheterization.
Catheter-related urosepsis is the most common source of gram-negative bacteremia in patients requiring hospitalization. Furthermore, urosepsis accounts for between 8 to 30% of all nursing home transfers to acute facilities.1 One can only imagine the annual cost to private insurance companies, Medicare and Medicaid.
Chronic urinary retention in the male patient can be due to prostatic obstruction. However, a significant number of elderly male patients, often in nursing facilities, are still unable to void even after prostatic surgery. Both male and female patients often have urinary retention secondary to neural injury to the sacral portion of the cord or to the motor or sensory roots of the corda equina. This can be due to trauma, tumors, discogenic disease, tabes dorsalis, or congenital abnormalities such as meningomyelocele. Certain metabolic diseases, such as diabetes and pernicious anemia, can also affect the peripheral nerves and lead to a flaccid neurogenic bladder. These bladder problems are often aggravated, especially in men by prostatic obstruction. Associated pelvic floor muscle relaxation often causes overflow incontinence as well. Certain medications which may be essential for patient management, such as psychotropic and antihistaminic drugs, exert an anticholinergic effect on the bladder and may also add insult to injury.
At times, conditions such as multiple sclerosis may cause a dyssynergia of the bladder and external urethral sphincter, which is unable to relax sufficiently to allow the bladder to empty. This too can be a cause of urinary retention.
Thus, the two options of treating these patients with chronic urinary retention are intermittent catheterization, which can be done at home by the patient or family members, or some form of chronic catheterization either via the urethra or with a suprapubic catheter. With either of these methods, a foreign body is introduced chronically into the bladder, which if left in place without periodic changing will cause calcific encrustations to form on the internalized portion of the catheter. Also, everyone with an indwelling catheter will eventually have their bladder urine colonized with bacteria, which not infrequently, especially in immobile patients, may lead to urosepsisxe2x80x94a potentially life threatening condition.
The present invention alleviates these problems of the prior art by providing for a continent bladder access device. The present invention allows easy access to the bladder for emptying, yet at the same time achieves continence for the benefit of the patient, the family, and nursing staff. It incorporates a self-sealing load port and a valve connected to each other by way of a series of tubes. The valve is an extravesical four piece elliptical ring composed of two distinct pairs of opposing sections. A pair of rigid locking mechanisms closes the ring at the ends of the major axis. A pair of semi-rigid sections parallel the major axis. These two longitudinal sections feature opposing matching inflatable cuffs. After surgical implantation and requisite healing, the valve may be opened by finger pressure at the ends of the major axis, closing automatically upon release. Since a portion of the full-thickness bladder is brought through the center of the valve, cut, draped over it and sutured to the skin during the surgical procedure, there must be no compromise of blood supply to this portion of the bladder. While everything is healing, no pressure should be applied to the area. At a later date when the tissue is healed and blood supply established, the permanent opening in the bladder is controlled by the inflatable cuffs. Fluid is injected into the load port and the fluid flows through the series of tubes into the inflatable cuffs of the valve, thereby closing it at safe tissue pressures to achieve continence. When fluid is removed from the load port, the fluid is removed from the inflatable cuffs contracting them back toward their resting state. This allows for relaxation of the inflatable cuffs away from the bladder when an adjustment to the valve is necessary. Should fluid need to be added or removed, it can be done as an office procedure at any time by means of the self-sealing load port. For drainage, one need only push on each end of the valve causing the cuff section to open slightly. A catheter can now be inserted to drain the bladder.
The present invention can also be used as a closure control valve for other internal tubular organs, such as bowel or urethra.
This invention and its surgical method of insertion into the patient are less drastic than the prior art. The present device is not as complicated to insert and maintain as the devices of the prior art. Since the device is less complicated, the time it takes to insert such a device in surgery is significantly decreased. In addition, the device is designed to initially exert very low pressures on the healing tissues. Once healed, the inflatable cuffs can be activated for continence. Most importantly, the valve itselfxe2x80x94a foreign bodyxe2x80x94does not come in contact with the inside lining of the patient""s bladder. There is no possibility for valve encrustation to occur, and the potential for urosepsis is greatly reduced. The device is also simple enough for family members and nursing personnel to operate. Overall this present device and its method of insertion leads to reduced stress to the patient with reduced risk of infection or follow-up surgery.
It is an object of the present invention to provide a novel continent bladder access device.
It is another object of the present invention to provide a novel continent bladder access device that incorporates a valve to control access to the bladder.
Another object of the present invention is to provide a novel continent bladder access device that incorporates a valve with an elliptical shaped ring for placement around the bladder to control access to the bladder.
Yet another object of the present invention is to provide a novel continent bladder access device that incorporates a valve with an external elliptical shaped ring and an internal inflatable cuff system.
It is another object of the present invention to provide a novel continent bladder access device that incorporates two equal and opposite inflatable cuff sections which are joined by a locking mechanism at each end. The locking mechanisms provide fulcrum points for manually relaxing cuff pressure by deflecting the external elliptical ring.
An additional object of the present invention is to provide a novel continent bladder access device that incorporates a load port for injection of fluids into the interior inflatable cuff sections of the valve. This provides a means by which the bladder access device can be activated after healing and adjusted if the patient""s bladder thickness changesxe2x80x94without surgery.
An additional object of the present invention is to provide a novel continent bladder access device that can be surgically implanted with less stress on the patient.
Another object of the present invention is to provide a novel continent bladder access device that allows healing after surgical implantation without pressure on the bladder or surrounding tissue thus preventing tissue necrosis.
Still another object of the present invention is to provide a novel continent bladder access device that does not maintain any foreign body within the bladder which would cause urinary infection and encrustation of the foreign body.
Another object of the present invention is to provide a novel continent bladder access device that utilizes a valve that does not come into contact with the urine within the bladder, but allows access to the bladder.
In satisfaction of these and related objectives, Applicant""s present invention provides for a continent bladder access device having a load port connected to a control valve by way of a series of tubes. Applicant""s invention permits its practitioner to control access to a patient""s bladder by way of a control valve. Upon compressing the ends of the major axis of the elliptical valve with two fingers access can be achieved. When the valve is released, the valve closes automatically.